Clinical Research Coordinator
Company: Indiana University
Location: Indianapolis
Posted on: October 13, 2024
Job Description:
DepartmentHEREDITARY GENOMICS DIVISION (IN-HGN-IUINA)Department
InformationOne of the first human genetics departments in the
country, the Department of Medical and Molecular Genetics at IU
School of Medicine has a rich history of training geneticists and
genetic counselors and providing genetic consultation and
counseling services. Currently ranked 5th in the nation among
Genetics Departments for NIH Funding, received in 2023, the
department contributes to the understanding of numerous genetic
conditions through the integration of basic research in genetic and
genomic mechanisms, translational research in disease models, and
clinical trials in rare and common genetic diseases.Job Summary
- Initiates and conducts protocol review, evaluations, study
design, and risk assessments of clinical research studies.
Recognizes situations requiring prompt escalation and demonstrates
actions to minimize risks.
- Conducts study visit activities and coordinates screening,
consenting, and scheduling of tests, exams, and/or
non-medical/behavioral interventions and assessments involving
study subjects.
- Facilitates and performs various study activities including
site evaluation visits, study related meetings and training
sessions, study initiation visits (SIV) and monitoring visits.
- Manages all follow-up activities with subjects based on
protocols and oversees proper documentation at study
close-out.
- Participates in study budget negotiations and reconciles study
budget accounts.
- Develops informational materials for recruitment of subjects;
monitors enrollment goals and modifies recruitment strategy as
needed.
- Ensures compliance with regulations, including organizing
electronic files and/or filing regulatory documents appropriately;
prepares and submits Institutional Review Board (IRB) documents
(i.e., Informed Consent, advertisement, protocol and protocol
summary); prepares regulatory documents for sponsor.
- Identifies and selects potential subjects by reviewing existing
protected health information, screening subjects, and conducting
interviews; performs subject interviews and assessments for data
required by protocol(s).
- Follows up on study documentation with necessary stakeholders
(healthcare providers, study participants, laboratory personnel,
etc.)
- Reviews incoming subject adverse event (SAE) information,
assists PI in making submission determination of SAEs, and follows
up to determine resolution of adverse events.
- Conducts study-related non-medical/behavioral
assessments/interventions as well as study procedures/interventions
(appropriate licensure may apply).
- Records, documents, and reports protocol deviations and trial
changes to PI and sub-investigators.
- Stays up to date with knowledge of regulatory affairs and/or
issues.QualificationsCombinations of related education and
experience may be considered. Education beyond the minimum required
may be substituted for work experience. Work experience beyond the
minimum required may be substituted for education. EDUCATION / WORK
EXPERIENCERequired
- Bachelor's degree in science or a health-related field and 1
year of clinical research experience; OR
- Associate's degree in science or a health-related field and 2
years of clinical research experienceLICENSES AND
CERTIFICATESPreferred
- SOCRA/ARCP Clinical Research Certification upon date of
hireSKILLSRequired
- Demonstrated analytical skills
- Ability to simultaneously handle multiple priorities
- Possesses strong technical aptitude
- Demonstrates a high commitment to quality
- Excellent organizational skillsWorking Conditions / DemandsThe
role regularly requires the ability to effectively communicate. The
role frequently requires the ability to move about the work
environment and to position oneself to operate laboratory equipment
effectively. The role requires the ability to move objects weighing
up to 25 pounds and will occasionally work near moving mechanical
parts. The person in this role must be able to perform the
essential functions with or without an accommodation.Work
LocationIU IndianapolisThis position is eligible for remote work or
in-person work. However, this is subject to change in the future
based on university policy and business needs.Advertised
Salary$49,505.00 - $59,505.00 per year based on experience and
internal equity within the department. Benefits OverviewFor
full-time staff employees, Indiana University offers a wide array
of benefits including:
- Multiple plan options for medical insurance
- Dental insurance
- Health Savings Account with generous IU contribution
- Life insurance, LTD, and AD&D options
- Base retirement plan contribution from IU, subject to
vesting
- Additional supplemental retirement plan options
- Tuition benefit for IU classes
- 10 paid holidays per year
- Generous Paid Time Off
- Paid Parental Leave
- Employee Assistance Program (EAP)Learn more about our benefits
by reviewing our online Benefits Brochure.Job ClassificationCareer
Level: CoreFLSA: ExemptJob Function: ResearchJob Family: Clinical
Research Click here to learn more about Indiana University's Job
Framework.Posting DisclaimerThis posting is scheduled to close at
11:59 pm EST on the advertised Close Date. This posting may be
closed at any time at the discretion of the University, but will
remain open for a minimum of 5 business days. To guarantee full
consideration, please submit your application within 5 business
days of the Posted Date.If you wish to include a cover letter, you
may include it with your resume when uploading attachments.Equal
Employment OpportunityIndiana University is an equal employment and
affirmative action employer and a provider of ADA services. All
qualified applicants will receive consideration for employment
based on individual qualifications. Indiana University prohibits
discrimination based on age, ethnicity, color, race, religion, sex,
sexual orientation, gender identity or expression, genetic
information, marital status, national origin, disability status or
protected veteran status. Indiana University does not discriminate
on the basis of sex in its educational programs and activities,
including employment and admission, as required by Title IX.
Questions or complaints regarding Title IX may be referred to the
U.S. Department of Education Office for Civil Rights or the
university Title IX Coordinator. See Indiana University's Notice of
Non-Discrimination here which includes contact information.Campus
Safety and SecurityThe Annual Security and Fire Safety Report,
containing policy statements, crime and fire statistics for all
Indiana University campuses, is available online. You may also
request a physical copy by emailing IU Public Safety at iups@iu.edu
or by visiting IUPD.Contact UsRequest SupportTelephone:
812-856-1234
Keywords: Indiana University, Lawrence , Clinical Research Coordinator, Healthcare , Indianapolis, Indiana
Didn't find what you're looking for? Search again!
Loading more jobs...